Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01381705
First received: June 23, 2011
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.


Condition Intervention
Lymphoma
Biological: rituximab
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Official Title: Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of FCGR3A 158V/F polymorphisms with response, duration of response, and time to rituximab resistance

Secondary Outcome Measures:
  • Copy number variation in FCGR3A cohort [ Designated as safety issue: No ]

Estimated Enrollment: 259
Study Start Date: June 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.
  • Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance.

Secondary

  • Quantify copy number variation in FCGR3A in this cohort.

OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with indolent follicular lymphoma
  • Treated on RESORT trial (ECOG-E4402) comprising rituximab monotherapy and then randomized to rituximab maintenance therapy or retreatment with rituximab upon disease relapse

    • Blood and tissue samples from patients available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381705

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Brad S. Kahl, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01381705     History of Changes
Other Study ID Numbers: CDR0000701978, ECOG-E4402T2
Study First Received: June 23, 2011
Last Updated: June 28, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014